Accelerate Your FDA Filings

Put the FDA in the palm of your hand with revolutionary predictive intelligence that reduces filing time and improves accuracy.

SubmittalIQ harnesses cutting-edge artificial intelligence to predict FDA feedback and submission outcomes with unprecedented precision, transforming pharmaceutical regulatory strategies and dramatically reducing time-to-market.

Real feedback. Real data. When you need it.

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>Predictive Analytics Redefined

Predictive Analytics Redefined

Our tool analyzes complex FDA precedent patterns to provide predictive feedback. And our tool allows you to interface and ask questions to improve your regulatory strategy. And the answers? All based on data. No more guessing.

Real Time Regulatory Intelligence

Real-Time Regulatory Intelligence

Advanced risk assessment algorithms dynamically evaluate submission complexity and potential regulatory challenges with precision, giving you the answers you need when you need them.

Predictive Modeling Magic

Predictive Modeling Magic

Our cutting-edge AI algorithms decode complex FDA approval patterns, giving pharma, biotech, and medical device companies unprecedented insights into submission strategies.

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FDA Submission Intelligence Decoded

AI Technology

Our proprietary machine learning algorithms analyze decades of FDA submission documents, predicting approval probabilities with unprecedented accuracy and insights.

Data Security

The tool is custom-fit for your organization. No fear of sharing your trade secrets. No fear of model collapse.

Continuous Learning

Our AI models evolve learning from each submission to provide increasingly refined predictions and strategic recommendations.

Chief Regulatory Affairs Officer

SubmittalIQ dramatically transformed our FDA submission process, reducing review times by 67%, increasing first-pass approval probability with its groundbreaking AI predictive analytics all while greatly reducing costs.

-You

Chief Regulatory Affairs Officer
AI Submission Mastery

Master FDA Submissions

Revolutionize your FDA submission process with cutting-edge AI strategies that predict approval probabilities and reduce guesswork.

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